To reverse the growing trend of ethics violations, CME providers and industry representatives need to stop pointing fingers--and collaborate on solutions.
It's no good saying, 'If physicians didn't take the gifts, companies wouldn't offer them.' We all need to work together to identify the problems and solutions."
Norman B. Kahn, MD, vice president, education and science, American Academy of Family Physicians, Kansas City, Mo., was interrupting the blame game that had erupted during a lively basics session at the American Medical Association's Tenth Annual Conference of the National Task Force on CME Provider/Industry Collaboration, convened this past September in Washington, D.C.
The issue in contention was the growing trend of ethics violations in the CME world. Attendees pointed fingers in every direction: pharmaceutical companies that lure physicians with expensive gifts and trips, physicians who are all too eager to accept, and CME providers who allow sales reps to dictate program content.
Then came Kahn's point: Everyone needs to take responsibility. Regardless of your role in CME, if you allow promotional programs to masquerade as unbiased, independent medical education, you're part of the problem.
Forgetting the Past Forget the past, and you are doomed to repeat it, warned one attendee, paraphrasing the famous aphorism.That's just what may be happening in the CME world. It's been ten years since Congressional hearings run by Senator Edward Kennedy (D-Mass.) exposed industry-run physician junkets held under the guise of medical education. The CME community reacted by taking steps to regulate itself; the Accreditation Council for CME issued its Standards for Commercial Support of CME, and the AMA formulated its Ethical Opinion on Gifts to Physicians From Industry.
But a whole new generation of providers, physicians, and industry staff, from CEOs to local reps, have entered the medical education field in the past decade, and many are unaware of the past problems, which is one factor, attendees said, that's driv-
ing the increase in ethics problems. Certainly, the field's newcomers did not experience first-hand the embarrassment and pain of nationwide press and public scrutiny.
Another factor that appears to be accelerating the trend is the recent court decision limiting the FDA's authority to control drug companies' participation in CME. (See sidebar, "Standing Alone," right.)
"There is a philosophy in some companies, that if you don't get your hand slapped, you're not doing your job," said panelist David F. Lichtenauer, president, Medical Education Consultants in Indianapolis "That bothers me."
The marketplace is not rewarding compliance, agreed Michael J. Scotti, vice president, medical education, AMA. "Noncompliance is being rewarded."
The problem is not one-sided. Taking the whole CME community to task, Sue Ann Capizzi, CEO, American Board of Psychiatry and Neurology, Deerfield, Ill., said, "We can fool the Standards. We do it every day. I wonder, how long can we get away with it? What will happen when the credibility of the, the trust we have gained, is eroded?"
The ACCME and AMA guidelines may have staved off government intervention in medical education for the past decade, but by flagrantly violating those guidelines, the medical community is once again risking public exposure and government regulation, warned another panelist, who asked later not to be identified.
She said she hears from industry that today's medical education environment has been likened to the environment of the early 1990s, and that, increasingly, promotional events are connected with CME activities, with companies, for example, giving physicians tickets to plays and ball games, and taking them on exotic trips.
"Are we OK with the current reality and its possible impact on public health?" she challenged attendees. "If we don't do something soon, Congress will do something for us."
Solution: Education The solution, attendees agreed, is to raise the level of knowledge about ethics and regulations among the players on all sides of the industry. The AMA's Council on Ethical and Judicial Affairs is exploring ways to reactivate the Opinion and raise awareness, said Lichtenauer. Meanwhile, providers and industry can initiate proactive strategies.
Physicians need to be reminded that "the smell test still applies," he said. "If you can't tell your patient about it, don't do it."
There has been an explosion of "branding events" held by industry, said AMA's Scotti, and physicians are sometimes confused about the difference between those promotional events and CME--as the content at both types of events appears similar. Because of that atmosphere, CME providers need to be proactive, he said.
One attendee said that at her annual meeting she has incorporated sessions for physicians about recognizing conflicts of interest.
"We are trying to get the word down to the level of the practitioner," she said.
But not everyone agreed that physicians are being duped by industry. A physician from industry, who asked later not to be identified, reported that doctors tell him that they colloborate with industry with no intention of being compromised.
"Doctors feel they understand the problem and take care so they won't be influenced," he said. I'm not sure physician ignorance is the problem. I'm concerned that we are headed toward the wrong diagnosis, and that we'll put our energy into solving the wrong problem."
There was, however, general agreement that sales reps were in dire need of education. Meetings are one vehicle associations are using to accomplish that goal. To inform industry reps about the ACCME and AMA guidelines, the Institute for Research and Education HealthSystem Minnesota in Minneapolis holds quarterly meetings, said Kathleen Sheldon, the organization's manager of industry relations.
While attendees from both sides--industry and medical associations--agreed they needed to share
responsibility for educating reps, providers have more at stake, she said.
"The bottom line," said Sheldon, is "if your accreditation gets yanked--it's your problem."
All Must Collaborate While attendees didn't decide on industry-wide initiatives, the conference provided a forum for airing problems and communicating across the barriers that divide industry and providers. There seemed to be agreement that players from all sides of the CME community had to work together.
Effecting change "requires the cooperation of the entire CME community: for-profit communication companies, hospitals, academic centers," Lichtenauer said. "I hope that for-profit and not-for-profit [providers] work together to deliver information." i
Standing Alone On September 3, just weeks before the American Medical Association's Tenth Annual Conference of the National Task Force on CME Provider/Industry Collaboration, the FDA filed an appeal of the court ruling restricting its authority over drug companies' participation in CME. In his July 1998 decision, U.S. District Court Judge Royce C. Lamberth ruled that FDA regulations on industry promotion of off-label drugs and devices were a violation of manufacturers' commercial speech rights. He specifically stated that the FDA cannot restrict manufacturers from:
* distributing articles and books about off-label uses, or
* suggesting content or speakers to independent CME providers.
The lawsuit was brought by the Washington Legal Foundation, a nonprofit organization that fights government regulation and advocates for free speech.
The legal haggling could go on for years. For now, the ruling means that accredited CME programs are no longer the only legally sanctioned forum for education about off-label uses of drugs and devices. It also creates a great divide between the regulations imposed on drug companies by the FDA, and the guidelines CME providers follow as mandated by the ACCME.
The potential effect of the decision was the top subject of concern at last year's conference, and it still generated much discussion this year. Will industry respond by attempting to exert more control over CME programs? The consensus seems to be, yes.
Calling the ruling "one of the most significant decisions in decades," attorney David Bloch, Reed Smith Shaw & McClay, LLP, Washington, D.C., said that it left a lot of room for interpretation, which, he joked, "will keep lawyers like me busy for some time." Bloch expects the FDA to be cautious about investigating violations while the case is on appeal. "I don't see the FDA [taking] an Eliot Ness-like attitude." Speaking to industry representatives in attendance, he said that while before the ruling "you had to go through ballet-like maneuvers to get your investigator on a panel at a program, now you can give [providers] a list [of suggested speakers]." That's just what providers are worried about.
However, he reminded attendees that the court's ruling specifically allows input only when the CME provider and program are "independent." He suggested that industry still follow the FDA's previous guidance on CME.
He also encouraged industry to follow the CME world's rules. "Don't forget the AMA," he said. "You don't want to cross them."
But even with those stipulations, some attendees expressed concern that industry would now try to pressure providers to bend the ACCME rules.
"The floodgates are open. Some in the industry see this as a golden opportunity to control CME speakers and content," said another speaker. "The legal silence leaves us in the dark. The ACCME standards are the only game in town."
For more information, see MM December 1998, page 42; and MM September/October 1999, page 12.
No Rules for Cyber CME For providers anxiously awaiting guidance on cyber CME, the news from the conference was not any more encouraging than it was last year (see MM December 1998, page 44). Neither the FDA nor the Accreditation Council for CME has plans to release specific guidelines on Web CME, reported speakers, although the AMA and ACCME have established subcommittees to
investigate the issue.
"The Internet is just a different method of delivery," said Kate Regnier, assistant executive director, ACCME. "That may be too simplistic, but before we create a policy that may be obsolete [by the time we issue it], we want to talk to all the players."
Meanwhile, providers should follow the guidelines for enduring materials, suggested Dennis K. Wentz, MD, director, division of CPPD (Continuing Physician Professional Development), AMA. Apply the values expressed by the ACCME's Standards for Commercial Support of CME, added Robert Orsetti, vice president, Medical Education Collaborative. During an informal meeting on the subject with CME leaders, he said, the main issue that came up was inappropriate linkages, where doctors "were faked out" when they clicked from an education page to a promotion page without any warning. Physicians should choose when to go to a promotional site; it should not be an automatic click through, Orsetti explained. He also said that advertising banners should not be around educational pieces. In other words, providers should separate promotion and advertising from education, just as they are supposed to do when using other delivery methods.
Keep Up with CME Change Do you want to keep current on the American Medical Association fight to reverse the trend of ethics violations? Find out the latest about its controversial proposal to institute a CME content registration or approval system? Those are just a few of the articles featured in the AMA's recently launched newsletter, The CME/CPPD Report. Also included is a calendar of upcoming events for providers.
The newsletter is free and you don't need to be an AMA member to subscribe. For information, phone Regina Littleton, editor, division of CME, AMA, at (312) 464-4637 or send e-mail to firstname.lastname@example.org